PharmaCyte Biotech Ready to Submit Investigational New Drug Application to FDA for Clinical Trial in Pancreatic Cancer - Seite 2

Of note, a DMF is a prerequisite to securing approval and commercialization and “ensures confidentiality of proprietary information” related to the Active Pharmaceutical Ingredient (API).  It is this confidentiality that is sacred to both Austrianova and PharmaCyte and exactly why it’s one of the very last items to be crossed off the lengthy checklist before the IND can be submitted.

Dr. Salmons agrees, “Information on the drug product must be included in the IND and detailed information on, among other things, the manufacture and testing of the drug product, is contained in the DMF. So, in a way, it can be considered the final piece of the puzzle.”

In reality, just 2 items remain before PharmaCyte can submit its IND and both will likely be accomplished in the coming days.  In a June 23^rd press release, PharmaCyte announced a list of tasks that needed to be completed before it could submit its IND to the U.S. FDA.  Most of that work was performed by PharmaCyte’s consultants and has been completed.

PharmaCyte’s CEO, commenting on the status of the IND, said, “Virtually all of the IND has been completed.  During the last few months, we have completed the Trial Protocol, the Investigator’s Brochure, the Environmental Analysis, the General Investigation Plan, the Introduction Summary, the Nonclinical Overview, the Clinical Overview, the Nonclinical Written and Tabulated Summaries, the Pharmacy Manual, the Study Reports and related information of the prior clinical studies pertinent to the treatment for LAPC, the Regulatory Publishing of the IND and supporting documents, and the Drug Master File.  Some of these documents are being updated with new data.  

“So, we’re now left with completing the Informed Consent, which is being prepared by our Principal Investigator, Dr. Manuel Hidalgo and his staff, and we need to hire a Chief Medical Officer (CMO) in oncology to represent the company’s interest in the planned clinical trial.  Two well-qualified candidates have been interviewed and the selection process is nearly complete.  We expect that both the Informed Consent and the hiring of a CMO should be completed over the next week. When this is complete, we plan to file the long-awaited IND.”